How to provide the proper access for innovative treatment

to the patients in Poland?Let’s discuss about new trends and planned

changes…

Dr Joanna LisPresident-Elect Polish Society of Pfarmacoeconomics

Expentitures on health care in Poland are not to high

as…

Public expenditure on health [Exch. rate, million US$]

Slova

k Rep

ublic

Hungary

Czech Rep

ublic

Finlan

d

Irelan

d

Greece

Poland

Denmark

Austria

Swed

enSp

ain Italy

France

German

y0

50,000

100,000

150,000

200,000

250,000

300,000

3,8877,236

10,03015,038

15,95218,099

19,33025,593

28,73633,601

87,353

141,304

225,546

266,179

Source: OECD Health Data 2009: data from 2007 year

Poland

Slova

k Rep

ublic

Hungary

Czech Rep

ublic

Greece

Finlan

d

Irelan

dSp

ain Italy

Swed

en

Austria

German

y

Denmark

France

-3.0%

0.0%

3.0%

6.0%

9.0%

12.0%

15.0%

4.6% 5.

2%

5.2% 5.

8%

5.8% 6.

1%

6.1%

6.1% 6.

7% 7.4% 7.

7% 8.0% 8.2% 8.

7%

Expenditure [Exch. rate, million US$]

Expenditure as % GDP

PUBLIC EXPENDITURE ON PHARMACEUTICALS AND OTHER MEDICAL NON-DURABLES* [Exch. rate, million US$]

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

* expenditure on pharmaceuticals and other medical non-durables comprises pharmaceuticals such as medicinal preparations, branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals and oral contraceptives.

Source: OECD Health Data 2009, data from 2007 year

Denmark

Finlan

d

Poland

Swed

en Italy

Austria

Czech Rep

ublic

France

German

ySp

ain

Hungary

Slova

k Rep

ublic

Greece

0.0%

0.2%

0.4%

0.6%

0.8%

1.0%

1.2%

1.4%

1.6%

1.8%

2.0%

0.5%

0.6%

0.6%

0.7%

0.8%

0.9%

1.0%

1.2%

1.2%

1.3%

1.4%

1.5%

1.9%

Expenditure [Exch. rate, million US$]

Expenditure as % GDP

State expenditures on therapeutics groups – 2007

Antineoplastic and immunomodulating agents;

6,27%

Systemic hormonal preparations, excluding sex

hormones and insulins;1,23%

Genito-urinary system and sex hormones ;

3,98%

Alimentary tract and metabolism ;

15,52%

n/a ; 7,92%

Respiratory system; 1,42%

Antiparasitic products, insecticides and repellents;

0,08%

Antiinfectives for systemic use;

7,35%

Dermatologicals ; 0,71%

Cardiovascular system; 14,68%

Blood and blood forming organs; 5,02%

Respiratory system 14,28%

Nervous system; 16,02%

Musculo-skeletal system; 3,99%

VARIA; 1,55%

Source: National Health Found, Report 2008

Level of health care expenditure vs quality of diabetic health care

◦ corelation between level of health care expenditure vs quality of diabetics health care

◦ 0,74 (p<0,05)

Wydatki na ochronę zdrowia 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z cukrzycą

AUS

BEL

BŁG

CYP

CZE

DAN

EST

FIN

FRA

GRE

HISZ

HOL

IRL

LIT LUXŁOT

MAL

NIE

NOR

POL

PORRUM

SK

SLO

SZWCSZWE

WĘG

UK

WŁO

0 500 1000 1500 2000 2500 3000 3500 4000 4500

wydatki na ochronę zdrowia per capita 2006 (USD, ppp)

450

500

550

600

650

700

750

800

850

900

RA

NK

ING

SY

ST

EM

ÓW

OP

IEK

I NA

D P

AC

JEN

TAM

I ZC

UK

RZ

YC

Ą

Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)

Level of health care expenditure vs quality of health care in cardiovacular

Strong corelation between level of health care expenditure vs quality of health care in cardiology

0,84 (p<0,05)

Wydatki na ochronę zdrowia per capita w 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z chorobami serca

AUS

BEL

CYP

CZE

DAN

EST

FIN

FRA

GRE

HISZ

HOL

IRL

LIT

LUX

ŁOT

MALNIE

POL

POR

SK

SLO SZW

WĘG

UKWŁO

0 500 1000 1500 2000 2500 3000 3500 4000 4500

WYDATKI NA OCHRONĘ ZDROWIA PER CAPITA 2006 (USD, PPP)

450

500

550

600

650

700

750

800

850

900

RA

NK

ING

SY

ST

EM

ÓW

OP

IEK

I NA

D P

AC

JEN

TAM

I ZC

HO

RO

BA

MI S

ER

CA

Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)

Payer perspective: Necessity to control of the

HC expenditures …

           

 PRICE CONTROL x VOLUMEN CONTROL  = SPENDING CONTROL

SUPPLY

PRICE REGULATIONSj, (freezing, lowering, …)

 CUT TING COSTS FOR

MARKETING  RSS

NATIONAL REFERENCE PRICING

International Price Comparisons

 PRODUCT VOLUME

CAPS  REVENUE CONTROL

"Cost-effectiveness pricing"       PROFIT CONTROL

REBATES       PRODUCT RENEVUE CAPS 

VBP        

DEMAND

PATIENT’S COPAYMENT   FOLUMULARIES   PATIENT/DISEASE BUDGET

REGISTRATION & MARKET AUTHORISATION RULES

 POSITIVE/NEGATIVE

REIMBURSEMENT LISTS  PHYSICIAN RX BUDGET

INSURANCE SYSTEM  CONTROL

PRESCRIPTION 

PHUSICIAN HEALTH CARE BUDGET

GENERIC SUBSTITIUTION   TRATMENT GUIDELINES  

TAXES   PARALLEL TRADE    

           

10

MoH Legislative road map in PolandName Merits Advance

Pharma Law

Amendment implementing EU DirImportant: introduction of 8+2+1 RDP regime

Consulted in 2009

Clinical trials

Assumptions of new Law ( single act) Important: - New (obligatory) insurance for each participant- 1 trials at a time by one investigator

Consulted in Jan’10

Registra-tion

New law on Regulatory Office Important: MA issued by President of Reg. Office (not MoH)

Consulted in 2009

Reimbur-sement

New reimbursement law : expected important changes: Individual decisions Fixed margins and prices Risk-sharing agreements Tax on pharma activities (Garattini tax)

Not Consulted yet

Doctors Draft law on New types of specializations Consulted Jan 2010

Clinical hospitals

New regime of clinical hospitals (erected by Medical Universities)

n/a

11

MoH Legislative Assumptions in Poland: Risk Sharing Agreements

CompanyMoH

risk- sharing

agreem.

conditionalreimbursement

Healthoutcome

Financialoutcom

population based

individualpatient based

pay forperformance

Coverage with clinical evidence development

Payment for treatment continuation only

Payment for treatment outcome

Upfront payment refunded in case of no treatment outcome

Defined market share and overspendings’ pay-back

Defined volume and overspendings’ pay-back

Limited no of treatment

Natural rebate

DRAFT!

Tools for new planned solutions in health care

system in Poland are needed…

A complete assessment of health technology comprises the following analyses:

1) Analysis of decision problem 2) Clinical effectiveness analysis

3) Economic analysis

4) Analysis of impact on health care system

Guidelines for conducting Health Technology Assessment (HTA)

Analysis of impact on health care system

covers ◦ the budget impact analysis and

◦ the assessment of organizational consequences for the heath care system, and possibly the assessment of possible ethical and social implications

Guidelines for conducting Health Technology Assessment (HTA) - BIA

◦ Lantus utilization after reimbursement decision

Future expenditures on Lantus after its reimbursement are calculated based on predicted use of Lantus given in international units (IU).

Share of estimated consumption of Lantus within basal insulin market was estimated on the basis of data from European countries where Lantus is reimbursed.

◦ Lantus utilization without reimbursement decision

Values for this forecast was obtained based on the dynamics of the consumption of Lantus in Poland (IMS Health data)

◦ Insulin dosage Calculator gives the opportunity to use input data on insulin dosage

from RCTs, observational studies or market research studies

EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes for LAA

* HTA Consulting, 2010

EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes

DAILY INSULIN DOSES (IU)

Insulin RCT Observational studies Market research study

Lantus 39 23,1 27,9

NPH 37 23,1 28,3

Premixed insulin 46,5 35 41,2

Proportions of use between Lantus and other insulin

Insulin RCT Observational studies Market research study

NPH 0,94 1,00 1,01

Premixed insulin 1,19 1,59 1,48

HTA Consulting, 2010

Utilization of insulin glycaemic test strips

Comparison of use of test strips in addition to insulin therapy indicates differences between patients on Lantus, NPH and premixes.

Compared to NPH/Premixes Lantus requires less strips. ◦ The difference is 20 less strips a month for new patients starting therapy and ◦ 13 strips a month for patients using insulin for before

Insulin prices

Perspective of the analysis: The analysis was conducted from public payer (NHF) and patient perspective.

Time horizon The analysis was conducted in 5 years perspective.

EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes

HTA Consulting, 2010

Replacement (switching) of insulin (NPH and premixes) by Lantus

Based on the insulin utilization from European countries (analysis of the structure of insulin market relating to replacement of NPH and premixes after Lantus reimbursement)

User can choose: ◦ Selected country (choice between different European

countries can be made) ◦ European mean calculated as arithmetic mean◦ European mean calculated as mean weighted by

population size ◦ European mean calculated as mean weighted by insulin

utilization ◦ User prognosis – user can choose the degree of share

between NPH and Premixes which are replaced by Lantus

Data on consumption of different types of insulin, together with the characteristics that describe the dynamics of the consumption trends (for the sample country (Greece))

EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes

HTA Consulting, 2010

Insulin utilization and trends used in the prognosis in Greece

2010 2011 2012 2013 2014-20,000,000

-15,000,000

-10,000,000

-5,000,000

0

5,000,000

10,000,000

15,000,000

20,000,000

Reimbursement by payer – scenario with OADs

LantusNPHMieszankiMetforminaGlimepirydPaski glikemiczne

YEAR

Refu

ndac

ja N

FZ [m

ln P

LN]

HTA Consulting, 2010

2010 2011 2012 2013 2014-200,000,000

-150,000,000

-100,000,000

-50,000,000

0

50,000,000

100,000,000

150,000,000

200,000,000

250,000,000

Insulins usage

Lantus NPH

Mix

Rok

Zuży

cie in

sulin

[mln

IU]

HTA Consulting, 2010

2010 2011 2012 2013 2014-25,000,000

-20,000,000

-15,000,000

-10,000,000

-5,000,000

0

5,000,000

10,000,000

15,000,000

20,000,000

Reimbursement by payer – scenario without OADs

LantusNPHMieszankiMetforminaGlimepirydPaski glikemiczne

Rok

Refu

ndac

ja N

FZ [m

ln P

LN]

Analysis of impact on health care system

ECONOMIC

SOCIAL

NEGOTIATIONin

RSS

ORGANIZATION

ETHICS

New Changes to Reimbursement Law in Poland is planned soon … Individual decisions: changes to administrative procedures leading to full

implementation of EU Transparency Directive No 105. Decisions are to be taken in the individual form Drugs reimbursement lists will be often updated and published in form of internal MoH

order/ not as legal Act published in Official Journal. New bodies will be introduced: Transparency Council and Economic Committee which

will conduct negotiations with pharmaceutical companies Fixe margins and prices

Rebates will be forbidden as well as all kinds of commercial practices concerning decreasing of ex-factory official price.

Pharmacy margins will be accounted from reimbursement limit/ not from the price. Risk-sharing agreements

Arrangements between a payer and a pharmaceutical, device, or diagnostic manufacturer

Tax on pharma activities („Garattini tax”) 3% of reimbursed drugs sales paid by Pharmaceutical Companies to the state budget. This money are going to be spent on independent clinical trials and registers (CER)

Others: Limits will be based on the cheapest drug with 15% market share level in therapeutic

group. Constant cost-reevaluation under reference price system

In case of lack of head to head trials comparing directly an assessed and an alternative technology, it is recommended to conduct an indirect comparison.

Indirect comparisons can be performed and presented independently of direct comparisons. In the case of mixed comparisons involving both direct and indirect comparisons, the results of direct comparisons alone should be presented separately and independently from the results of the mixed comparison.

Guidelines for conducting Health Technology Assessment (HTA) in Poland – Relative Effectiveness

Health Technology Assessment

Evidence Based Medicine

E

F

F

I

C

A

C

y

Does

it W

ork

?

For

whom

?

Com

para

tive

Cost

EFFECTIVENESS

Health Technology Assessment

Evidence Based Medicine

E

F

F

I

C

A

C

y

Does

it W

ork

?

For

whom

?

Com

para

tive

Cost

EFFECTIVENESS

The structure remain but the setting changes !

Comparative Effectiveness is the conduct and synthesis of research comparing the benefits and harms of different interventions in a „real world” settings. The purpose of this research is to improve health

outcomes by developing and disseminating evidence – based information to patients, clinicians and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances”

Additional taxes for financing CER

CER in Poland

How to provide the proper access for innovative

treatment to the patients in Poland?

CHANGES IN HEALTH CARE SYSTEM WHICH ALLOW TO GET BETTER ACCESS

WITHIN LIMITED RESOURCES

Let’s do together!